GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic
FDA device recall Z-0853-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 15. 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology / Surgery Department and Radiologists / Cardiologists / Surgeons. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. The letter stated that GE Healthcare will correct all affected systems at no cost. For questions call (In US 800-437-1171; for other countries contact your local GE Healthcare Service Representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 28 (12 US, 16 OUS).
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY.
- Date initiated
- 2013-11-15
- Date posted
- 2014-01-28
- Date terminated
- 2014-03-28
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS (K122457) | GE Healthcare | 2013-01-02 |